Ismail A A A
Tanglewood, Chevet Lane, Wakefield, West Yorkshire WF2 6HL, UK.
J Clin Pathol. 2009 Aug;62(8):673-8. doi: 10.1136/jcp.2008.055848.
Full automation of laboratory procedures confers numerous advantages over semi-automated/manual tests because equipment, reagents and the computation of results are offered as an integrated package. Automation has allowed millions of immunoassay tests to be performed with good sensitivity and excellent precision but inaccuracy caused by interference from endogenous immunoglobulins/antibodies remained a problem (irrespective of the immunoassay's format). Interference leading to a falsely high or low result affects a specific sample and may not be obvious despite the strictest laboratory control schemes. Reporting and interpreting such potentially erroneous data remained however the responsibility of the clinical laboratory despite the limited information supplied by their providers. The focus of this review is on highlighting the potential downside of current disjointed and blurred arrangement between the developers/providers of immunoassays, and the laboratorians responsible for providing these data to their clinical colleagues. These limitations can be addressed by drawing attention to the importance of the key fundamentals underpinning these immunologically based analyses which, if carefully considered, could help to formulate pragmatic strategies to reduce errors in immunoassays. In this review, the inherent fallibility of the binding reaction between an antigen and antibody will be reiterated. The difficulties in defining reaction rate kinetics in non-equilibrium automated assays, the potential clinical error rate and the need for minimising analytical error rate of these automated technologies will be highlighted.
实验室程序的全自动化相较于半自动/手动检测具有诸多优势，因为设备、试剂以及结果计算都作为一个集成包提供。自动化使得数百万次免疫分析检测得以进行，检测具有良好的灵敏度和出色的精密度，但内源性免疫球蛋白/抗体的干扰导致的不准确问题仍然存在（无论免疫分析的形式如何）。导致结果假性偏高或偏低的干扰会影响特定样本，并且即使在最严格的实验室控制方案下也可能不明显。然而，尽管免疫分析供应商提供的信息有限，但报告和解释这些潜在错误数据的责任仍在于临床实验室。本综述的重点是突出免疫分析开发者/供应商与负责向临床同事提供这些数据的检验人员之间当前脱节且模糊的安排所带来的潜在不利影响。通过关注这些基于免疫分析的关键基础要点的重要性，可以解决这些局限性，若仔细考虑这些要点，有助于制定务实策略以减少免疫分析中的误差。在本综述中，将重申抗原与抗体之间结合反应固有的易出错性。将强调在非平衡自动化检测中定义反应速率动力学的困难、潜在的临床错误率以及将这些自动化技术的分析错误率降至最低的必要性。
